Bill · H.R. 340· House(119-HR-340)
The HCT/P Modernization Act of 2025
- Introduced
- 1/13/2025
- Last activity
- 1/13/2025 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Dan Crenshaw
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
The HCT/P Modernization Act of 2025 directs the Secretary of Health and Human Services to streamline the regulatory oversight of human cell and tissue products. The bill requires the publication of educational materials and best practices on the FDA website regarding the Tissue Reference Group. It also mandates the annual publication of specific data regarding registered establishments, inspections, and response times. Additionally, the Act directs the Secretary to provide information and conduct educational workshops for various stakeholders. The bill amends existing law to focus on generating scientific data for stem cell and other cellular therapies. Finally, it requires the establishment of a public docket and a report to Congress containing regulatory recommendations.
Yes· 3 of 5
Does this make what the government does easier for the public to see?+5
The bill mandates the publication of data regarding registered establishments, inspections, and response times on the FDA website.
Does this make health care easier to get in general?+4
The bill seeks to improve access to human cell and tissue products through regulatory modernization.
Does this put more money into medical research?+3
The bill focuses on generating scientific data necessary to facilitate the development of stem cell and other cellular therapies.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Transparency: The Secretary must publish data regarding the number of registered establishments, the number of inspections conducted, and average response times for the Tissue Reference Group (Section 3(a)(2)). This allows the public to see how these establishments are being overseen.
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Improved Accessibility of Information: The bill requires the publication of educational materials and best practices on the FDA website to help people get timely and accurate recommendations (Section 3(a)(1)).
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Stakeholder Support: The Secretary is tasked with providing information and conducting workshops for stakeholders, including patients, to support regulatory predictability and scientific advancement (Section 3(a)(3)).
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Development of Medical Products: The bill updates existing law to focus on generating scientific data necessary to facilitate the development of stem cell and other cellular therapies (Section 3(b)).
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Regulatory Refinement: The Secretary is directed to develop recommendations that take into account scientific developments, regulatory burden, and access to human cell and tissue products (Section 3(d)).
Potential Negative Impacts for People
- Regulatory Uncertainty: While the bill aims for predictability, the Secretary is tasked with considering the "regulatory burden" and "modernizing" regulations regarding minimal manipulation and homologous use (Section 3(c) and 3(d)), which involves ongoing assessments.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Improves Healthcare Access+4Increases Research Funding+3
- Governance And Ideology
- Improves Government Transparency+5
- Economy And Finance
- Improves Small Business Support+3
- Education And Technology
- Increases Scientific Research Funding+3
- 1/13/2025
- Referred to the House Committee on Energy and Commerce.
- 1 Cosponsor added.
- Introduced in House
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Nanette BarragánDemocrat · California